[Federal Register Volume 86, Number 4 (Thursday, January 7, 2021)]
[Proposed Rules]
[Pages 1030-1037]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28532]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1301, 1309, and 1321

[Docket No. DEA-587]
RIN 1117-AB58


Amending Regulations To Require Online Submission of Applications 
for and Renewals of DEA Registration

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of proposed rulemaking.

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SUMMARY: This rule proposes to amend the Drug Enforcement 
Administration (DEA) regulations to require all initial and renewal 
applications for DEA registration to be submitted online.

DATES: Electronic comments must be submitted, and written comments must 
be postmarked, on or before March 8, 2021. Commenters should be aware 
that the electronic Federal Docket Management System will not accept 
any comments after 11:59 p.m. Eastern Time on the last day of the 
comment period.
    All comments concerning collections of information under the 
Paperwork Reduction Act must be submitted to the Office of Management 
and Budget on or before March 8, 2021.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-587'' on all correspondence, including any 
attachments.
     Electronic comments: The Drug Enforcement Administration 
(DEA) encourages that all comments be submitted electronically through 
the Federal eRulemaking Portal which provides the ability to type short 
comments directly into the comment field on the web page or attach a 
file for lengthier comments. Please go to http://www.regulations.gov 
and follow the online instructions at that site for submitting 
comments. Upon completion of your submission, you will receive a 
Comment Tracking Number for your comment. Please be aware that 
submitted comments are not instantaneously available for public view on 
Regulations.gov. If you have received a Comment Tracking Number, your 
comment has been successfully submitted and there is no need to 
resubmit the same comment.
     Paper comments: Paper comments that duplicate electronic 
submissions are not necessary. Should you wish to mail a paper comment, 
in lieu of an electronic comment, it should be sent via regular or 
express mail to: Drug Enforcement Administration, Attn: DEA Federal 
Register Representative/DPW, 8701 Morrissette Drive, Springfield, 
Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting 
and Policy Support Section, Diversion Control Division, Drug 
Enforcement Administration; Mailing Address: 8701 Morrissette Drive, 
Springfield, Virginia 22152; Telephone: (571) 362-3261.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

    Please note that all comments received are considered part of the 
public record. They will, unless reasonable cause is given, be made 
available by the Drug Enforcement Administration (DEA) for public 
inspection online at http://www.regulations.gov. Such information 
includes personal identifying information (such as your name, address, 
etc.) voluntarily submitted by the commenter. The Freedom of 
Information Act applies to all comments received. If you want to submit 
personal identifying information (such as your name, address, etc.) as 
part of your comment, but do not want it to be made publicly available, 
you must include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the 
first paragraph of your comment. You must also place all of the 
personal identifying information you do not want made publicly 
available in the first paragraph of your comment and identify what 
information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the 
first paragraph of your comment. You must also prominently identify the 
confidential business information to be redacted within the comment.
    Comments containing personal identifying information or 
confidential business information identified as directed above will be 
made publicly available in redacted form. If a comment has so much 
confidential business information that it cannot be effectively 
redacted, all or part of that comment may not be made publicly 
available. Comments posted to http://www.regulations.gov may include 
any personal identifying information (such as name, address, and phone 
number) included in the text of your electronic submission that is not 
identified as confidential as directed above.
    An electronic copy of this proposed rule is available at http://www.regulations.gov for easy reference.

Legal Authority

    The Controlled Substances Act (CSA) grants the Attorney General 
authority to promulgate rules and regulations relating to: The 
registration and control of the manufacture, distribution, and 
dispensing of controlled substances and listed chemicals; reporting 
changes to professional or business addresses; and the efficient 
execution of his statutory functions. 21 U.S.C. 821, 822(a), 827(h), 
871(b), 957(a). The Attorney General is further authorized by the CSA 
to promulgate rules and regulations relating to the registration and 
control of importers and exporters of controlled substances and listed 
chemicals. 21 U.S.C. 958(f). The Attorney General has delegated this 
authority to the Administrator of DEA. 28 CFR 0.100(b).
    DEA Form 224 applies to new registration applications for retail 
pharmacy, hospital/clinic, practitioner, teaching institution, or mid-
level practitioner registrations.\1\ DEA Form 225 applies to new 
registration applications for manufacturer, distributor, researcher, 
canine handler, analytical laboratory, importer, or exporter 
registrations.\2\ DEA Form 363 applies to new registration applications 
for narcotic treatment program registrations.\3\ DEA Form 510 applies 
to new registration applications for domestic chemical 
registrations.\4\ DEA Forms 224a, 225a, 363a, and 510a apply to 
registration renewal applications.\5\
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    \1\ 21 CFR 1301.13(e)(1)(iv).
    \2\ 21 CFR 1301.13(e)(1)(1)(i)-(iii), (v)-(vi), and (viii)-(x).
    \3\ 21 CFR 1301.13(e)(1)(vii).
    \4\ 21 CFR 1309.21.
    \5\ 21 CFR 1301.13(e)(1) and 1309.21
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Purpose of the Proposed Rule

    The purpose of this notice of proposed rulemaking is to simplify 
the form submission process by requiring that all registration and 
renewal applications be submitted online. Currently, DEA regulations 
permit DEA Registration Forms (224/224a, 225/225a, 363/363a, and 510/
510a) to be submitted either through the secure online database, or by 
paper forms delivered to DEA Headquarters.\6\ This proposed rule will 
amend DEA regulations to require that all registration and renewal 
applications be

[[Page 1031]]

submitted through the secure online database, and that paper forms will 
no longer be accepted. Submission through the secure online database 
will be a streamlined process which will benefit both DEA and 
registrants.
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    \6\ https://www.deadiversion.usdoj.gov/drugreg/index.html#regapps.
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Discussion of Regulatory Changes

Need for Regulatory Changes

    Regulatory changes are needed to conform existing DEA regulations 
regarding the submission of registration and renewal applications to 
the Administration's current requirements that other DEA forms be 
submitted online. This rule proposes to amend existing DEA regulations 
in seven sections.\7\ Title 21 CFR 1301.13 and 1301.14 are proposed to 
be amended to remove the option to submit paper forms and provide 
instructions for online application and payment instructions. The rule 
also proposes removing 21 CFR 1301.14 (b), which will become obsolete 
with the adoption of the secure application portal. 21 CFR 1309.12 is 
proposed to be amended to clarify payment options. Title 21 CFR 1309.32 
is proposed to be amended to remove the option to submit paper forms 
and provide instruction for online applications and payments for listed 
chemical handlers. Title 21 CFR 1309.33 is proposed to be amended to 
clarify the online application and payment process while removing Sec.  
1309.33 (b), which will become obsolete with the adoption of the secure 
application portal. Title 21 CFR 1309.34 is proposed to be amended to 
clarify the handling of defective applications. Title 21 CFR 1321.01 is 
proposed to be amended to remove reference to submitting paper forms by 
mail to any DEA Registration Unit address.
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    \7\ 21 CFR 1301.13, 1301.14, 1309.12, 1309.32, 1309.33, 1309.34, 
and 1321.01.
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Regulatory Analyses

Executive Orders 12866, 13563, and 13771, Regulatory Planning and 
Review, Improving Regulation and Regulatory Review, and Reducing 
Regulation and Controlling Regulatory Costs

    This proposed rule was developed in accordance with the principles 
of Executive Orders (E.O.) 12866, 13563, and 13771. E.O. 12866 directs 
agencies to assess all costs and benefits of available regulatory 
alternatives and, if regulation is necessary, to select regulatory 
approaches that maximize net benefits (including potential economic, 
environmental, public health, and safety effects; distributive impacts; 
and equity). E.O. 13563 is supplemental to and reaffirms the 
principles, structures, and definitions governing regulatory review 
established in E.O. 12866.
    E.O. 12866 classifies a ``significant regulatory action,'' 
requiring review by the Office of Management and Budget (OMB), as any 
regulatory action that is likely to result in a rule that may: (1) Have 
an annual effect on the economy of $100 million or more or adversely 
affect in a material way the economy, a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or State, local, or tribal governments or communities; (2) 
create a serious inconsistency or otherwise interfere with an action 
taken or planned by another agency; (3) materially alter the budgetary 
impact of entitlements, grants, user fees, or loan programs or the 
rights and obligations of recipients thereof; or (4) raise novel legal 
or policy issues arising out of legal mandates, the President's 
priorities, or the principles set forth in the E.O. DEA has determined 
that this proposed rule is not a ``significant regulatory action'' 
under E.O. 12866, section 3(f).

Analysis of Benefits and Costs

    DEA has examined the benefits and costs of this proposed rule. 
There has been a continued decrease in the use of paper forms from 2016 
to 2020. Paper forms as a percentage of total applications decreased 
annually from 7.5 percent in 2016 to 2.8 percent, 1.5 percent, and 1.1 
percent, in years 2017, 2018, and 2019, respectively. In the first 
three months of 2020, 99.3 percent of all DEA registration forms were 
submitted electronically via DEA's secure website and 0.7 percent were 
submitted by paper. While it is possible the percentage of paper 
submissions will continue to drop, DEA believes 0.7 percent is a 
reasonable estimate. Therefore, this proposed rule will impact the 
remaining 0.7 percent of registration forms that are submitted by 
paper, approximately 4,453 registrations per year.\8\ Benefits include 
cost savings, as discussed in the following paragraphs, and increased 
simplicity in the registration process. This proposed rule will 
simplify the form submission process and require that all new 
applications and renewals be submitted online. Additionally, electronic 
submissions will increase efficiency and accuracy.
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    \8\ The average annual number of applications from 2017 to 2019 
is 636,097. 636,097 x 0.7 percent = 4,453.
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    There are no new costs associated with this proposed rule. The 
labor burden to submit an application is estimated to be the same for 
electronic and paper submissions. No special software is needed to 
complete an online application via DEA's public website. Furthermore, 
all applicants, including the estimated 0.7 percent of applicants using 
paper forms, are assumed to be able to access the internet without 
incurring additional costs. DEA believes providing a contact email 
address on the application is indicative of internet access. Although 
the applicant's contact email address is an optional field, virtually 
all paper submissions include contact email addresses.\9\ Although 
online applications are available at no additional cost, DEA 
acknowledges some applicants have a preference for paper forms. DEA 
does not have a basis to quantify this preference; however, DEA 
believes any cost of eliminating this preference is offset by the 
qualitative cost savings discussion below.
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    \9\ Based on review of applications from January 2020 to March 
2020, there were 307 applications for initial registration using the 
paper form. Six of 307 applications did not contain a contact email 
address. DEA believes it is likely the six applicants have email 
addresses (and have access to the internet), but opted to not 
provide the email address. Including the online applications, six of 
30,509 applications for new registrations over the three-month 
period, January-March 2020, did not contain email addresses.
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    DEA anticipates there will be cost savings associated with 
electronic submissions. Some cost savings are described qualitatively 
and some are quantified. Many paper submissions contain illegible or 
erroneous information or omit required information. Many such errors or 
omissions, such as not including a signature or paying the wrong amount 
require DEA to contact applicants for corrections or clarifications, a 
time-consuming process for both DEA and the applicant. Electronic 
submissions are expected to virtually eliminate the requirement for DEA 
to contact applicants for clarification of form data or for correction 
of submission errors, as validation features in the system will flag 
common errors before transmission. DEA has not tracked the number or 
the duration of such delays and does not have a strong basis to 
quantify these cost savings.
    This proposed rule would eliminate the need to print paper forms 
and transmit them by mail or courier service. DEA estimates there will 
be a cost savings of $0.63 ($0.55 for postage plus $0.08 for an 
envelope), or a total of $2,805 per year for an estimated 4,453 
responses per year. DEA assumes the cost savings associated with 
eliminating printing costs is negligible.

[[Page 1032]]

    Furthermore, DEA anticipates cost savings from the elimination of 
production costs (i.e., paper forms, envelopes, postage, equipment, and 
labor). Based on the information collection requests for the 
registration forms, recently approved by OMB, DEA's production costs of 
$49,910 will be eliminated.\10\ In summary, DEA estimates this proposed 
rule will result in an annual cost savings of $52,715 ($2,805 to 
applicants and $49,910 to DEA).
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    \10\ The estimated production cost is the sum of the estimated 
production cost for each of the forms. Office of Information and 
Regulatory Affairs, Inventory of Currently Approved Information 
Collections, April 13, 2020, https://www.reginfo.gov/public/do/PRAMain (accessed April 13, 2020). See Paperwork Reduction Act 
section below for specific OMB control numbers.
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    Section 2(a) of E.O. 13771 \11\ requires an agency, unless 
prohibited by law, to identify at least two existing regulations to be 
repealed when the agency publicly proposes for notice and comment or 
otherwise promulgates a new regulation. In furtherance of this 
requirement, Section 2(c) of E.O. 13771 requires that the new 
incremental costs associated with new regulations, to the extent 
permitted by law, be offset by the elimination of existing costs 
associated with at least two prior regulations. Because this proposed 
rule is estimated to have a total cost of less than zero (cost savings 
of $52,715 per year), DEA expects the rule will be considered an E.O. 
13771 deregulatory action.
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    \11\ 82 FR 9339.
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Executive Order 12988, Civil Justice Reform

    This proposed rule meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of E.O. 12988, Civil Justice Reform to 
eliminate ambiguity, minimize litigation, establish clear legal 
standards, and reduce burdens. DEA expects the instant validation of 
online registration applications to reduce ambiguity and reduce the 
number of errors in submissions and reduce burdens on both DEA and 
registrants.

Executive Order 13132, Federalism

    This proposed rule does not have federalism implications warranting 
the application of E.O. 13132. The proposed rule does not have 
substantial direct effects on the States, on the relationship between 
the National Government and the States, or on the distribution of power 
and responsibilities among the various levels of government.

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    The proposed rule does not have substantial direct effects on one 
or more Indian tribes, on the relationship between the Federal 
Government and Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.

Regulatory Flexibility Act

    In accordance with the Regulatory Flexibility Act (RFA), the DEA 
has reviewed the economic impact of this proposed rule on small 
entities. DEA's economic impact evaluation indicates that the rule will 
not, if promulgated, have a significant economic impact on a 
substantial number of small entities.
    The RFA requires an agency to analyze options for regulatory relief 
of small entities unless it can certify that the rule will not have a 
significant impact on substantial number of small entities. DEA has 
analyzed the economic impact of each provision of this proposed rule 
and estimates that it will have minimal economic impact on affected 
entities, including small businesses, nonprofit organizations, and 
small governmental jurisdictions.
    This proposed rule will simplify the form submission process by 
requiring all initial registration and renewal applications be 
submitted online. The rule would affect all applicants for DEA 
registration or re-registration who would use paper forms. There has 
been a continued decrease in the use of paper applications from 2016 to 
2020. Paper applications, as a percentage of total applications, 
decreased annually from 7.5 percent in 2016 to 2.8 percent, 1.5 
percent, and 1.1 percent, in years 2017, 2018, and 2019, respectively. 
In the first three months of 2020, 99.3 percent of all DEA Registration 
Forms were submitted electronically via DEA's secure website and 0.7 
percent were submitted by paper. While it is possible the percentage of 
paper submissions will continue to drop, DEA believes 0.7 percent is a 
reasonable estimate. Therefore, this proposed rule will impact the 
remaining 0.7 percent of registration forms that are submitted by 
paper, approximately 4,453 registrations per year.\12\
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    \12\ The average annual number of applications from 2017 to 2019 
is 636,097. 636,097 x 0.7 percent = 4,453.
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    All registration business activities (registrant-type) have used 
paper registration forms in the past three years. DEA estimated the 
number of applications by business activity based on the three-year 
average, 2017-2019, of actual paper application submissions. DEA 
applied the percentages for each business activity to the estimated 
4,453 paper registration per year. For example, on average, 5.73 
percent of total paper registration forms were for pharmacy 
registrations. Applying 5.73 percent to the 4,453 estimated total paper 
registrations, the estimated number of paper registrations for pharmacy 
registrations was 255 (4,453 x 5.73 percent). This calculation was 
conducted for each business activity and the results are in Table 1 
below.

                   Table 1--Percentage and Number of Paper Registrations by Business Activity
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                                       2017            2018            2019           Average        Number of
        Business activity            (percent)       (percent)       (percent)       (percent)     registrations
----------------------------------------------------------------------------------------------------------------
Pharmacy........................            3.12            6.25            7.81            5.73             255
Hospital/Clinic.................            2.11            2.67            3.57            2.78             124
Practitioner....................           79.73           77.99           74.13           77.29           3,442
Teaching Institution............            0.03            0.04            0.01            0.03               1
Manufacturer....................            0.23            0.33            0.39            0.32              14
Distributor.....................            0.15            0.18            0.28            0.20               9
Researcher/Canine Handler.......            3.00            3.61            2.96            3.19             142
Analytical Lab..................            0.41            0.53            0.51            0.48              22
Importer........................            0.07            0.10            0.10            0.09               4
Exporter........................            0.03            0.04            0.07            0.05               2
Reverse Distributor.............            0.01            0.02            0.04            0.03               1
Mid-level Practitioner (MLP)....           10.38            7.62            9.40            9.14             407
Narcotic Treatment Program......            0.38            0.33            0.38            0.36              16
Chemical Manufacturer...........            0.11            0.11            0.10            0.11               5

[[Page 1033]]

 
Chemical Importer...............            0.06            0.02            0.03            0.04               2
Chemical Distributor............            0.13            0.10            0.13            0.12               5
Chemical Exporter...............            0.03            0.04            0.09            0.05               2
                                 -------------------------------------------------------------------------------
Total...........................          100.00          100.00          100.00          100.00           4,453
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(Source: DEA)

    As this proposed rule affects all business activities that are 
required to obtain a registration with DEA pursuant to the CSA, this 
proposed rule would affect small entities in a wide variety of 
industries. Table 2 indicates the sectors, as defined by the North 
American Industry Classification System (NAICS), affected by the 
proposed rule. Most DEA registrants are, or are employed by, small 
entities under Small Business Administration (SBA) standards.

             Table 2--Industrial Sectors of DEA Registrants
------------------------------------------------------------------------
       Business Activity           NAICS Code     NAICS Code Description
------------------------------------------------------------------------
Manufacturer...................          325411  Medicinal and Botanical
                                                  Manufacturing.
                                         325412  Pharmaceutical
                                                  Preparation
                                                  Manufacturing.
Distributor, Importer, Exporter          424210  Drugs and Druggists'
                                                  Sundries Merchant
                                                  Wholesalers.
Reverse Distributor............            5621  Waste Collection.
                                           5622  Waste Treatment and
                                                  Disposal.
Pharmacy.......................          445110  Supermarkets and Other
                                                  Grocery (except
                                                  Convenience) Stores.
                                         446110  Pharmacies and Drug
                                                  Stores.
                                         452210  Department Stores.
                                         452311  Warehouse Clubs and
                                                  Supercenters.
Analytical Labs................          541380  Testing Laboratories.
Teaching institute.............          611310  Colleges, Universities
                                                  and Professional
                                                  Schools.
Researcher.....................          541715  Research and
                                                  Development in the
                                                  Physical, Engineering,
                                                  and Life Sciences
                                                  (except Nanotechnology
                                                  and Biotechnology).
Canine Handler.................          561612  Security Guards and
                                                  Patrol Services.
Practitioner, Mid-level                  541940  Veterinary Services.
 Practitioner,* Narcotic
 Treatment Program, Hospital/
 Clinic.
                                         621111  Offices of Physicians
                                                  (except Mental Health
                                                  Specialists).
                                         621112  Offices of Physicians,
                                                  Mental Health
                                                  Specialists.
                                         621210  Offices of Dentists.
                                         621330  Offices of Mental
                                                  Health Practitioners
                                                  (except Physicians).
                                         621391  Offices of Podiatrists.
                                         621420  Outpatient Mental
                                                  Health and Substance
                                                  Abuse Centers.
                                         621491  HMO Medical Centers.
                                         621493  Freestanding Ambulatory
                                                  Surgical and Emergency
                                                  Centers.
                                         622110  General Medical and
                                                  Surgical Hospitals.
                                         622210  Psychiatric and
                                                  Substance Abuse
                                                  Hospitals.
                                         622310  Specialty (except
                                                  Psychiatric and
                                                  Substance Abuse)
                                                  Hospitals.
Chemical Manufacturer..........             325  Chemical Manufacturing.
Chemical Distributor, Chemical           424690  Other Chemical and
 Importer, Chemical Exporter.                     Allied Products
                                                  Merchant Wholesalers.
------------------------------------------------------------------------
* Practitioners and mid-level practitioners are generally employed in
  one of these industries.

    As shown in Table 2, the proposed rule would affect a wide variety 
of entities across many industry sectors. As some industry sectors are 
expected to consist primarily of DEA registrants (i.e., 446110-
Pharmacies and Drug Stores, 622110-General Medical and Surgical 
Hospitals, etc.), this proposed rule is expected to affect some small 
entities. For reference, Table 3 lists the average annual revenue for 
the smallest of small businesses in each industry sector. The table 
below lists the results.

                          Table 3--Average Annual Revenue of Smallest of Small Entities
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                                                                                                      Average
                                                                    Enterprise       Number of      revenue per
           NAICS code                 NAICS code description       size  (number  establishments   establishment
                                                                   of employees)                        ($)
----------------------------------------------------------------------------------------------------------------
325............................  Chemical Manufacturing.........             0-4           3,148       1,938,546
325411.........................  Medicinal and Botanical                     0-4             108         727,444
                                  Manufacturing.
325412.........................  Pharmaceutical Preparation                 *5-9             129       2,639,287
                                  Manufacturing.
424210.........................  Drugs and Druggists' Sundries               0-4           3,630       1,367,131
                                  Merchant Wholesalers.

[[Page 1034]]

 
424690.........................  Other Chemical and Allied                   0-4           3,352       2,007,996
                                  Products Merchant Wholesalers.
445110.........................  Supermarkets and Other Grocery              0-4          23,710         453,787
                                  (except Convenience) Stores.
446110.........................  Pharmacies and Drug Stores.....             0-4           6,360       1,069,655
452112.........................  Discount Department Stores.....             0-4               6         266,167
452910.........................  Warehouse Clubs and                         0-4              12         326,333
                                  Supercenters.
541380.........................  Testing Laboratories...........             0-4           2,415         297,737
541712.........................  Research and Development in the             0-4           5,013         427,790
                                  Physical, Engineering, and
                                  Life Sciences (except
                                  Biotechnology).
541940.........................  Veterinary Services............             0-4           8,881         292,166
561612.........................  Security Guards and Patrol                  0-4           2,162         114,198
                                  Services.
5621...........................  Waste Collection...............             0-4           3,853         365,902
5622...........................  Waste Treatment and Disposal...             0-4             616         461,159
611310.........................  Colleges, Universities, and                 0-4             372         913,078
                                  Professional Schools.
621111.........................  Offices of Physicians (except               0-4          95,648         447,715
                                  Mental Health Specialists).
621112.........................  Offices of Physicians, Mental               0-4           8,980         253,837
                                  Health Specialists.
621210.........................  Offices of Dentists............             0-4          50,781         330,868
621320.........................  Offices of Optometrists........             0-4          10,939         269,348
621330.........................  Offices of Mental Health                    0-4          16,149         145,005
                                  Practitioners (except
                                  Physicians).
621391.........................  Offices of Podiatrists.........             0-4           5,300         288,546
621420.........................  Outpatient Mental Health and                0-4           1,810         211,249
                                  Substance Abuse Centers.
621491.........................  HMO Medical Centers............           * 5-9              16         620,188
621493.........................  Freestanding Ambulatory                     0-4           1,011         549,974
                                  Surgical and Emergency Centers.
622110.........................  General Medical and Surgical                0-4              39      10,621,308
                                  Hospitals.
622210.........................  Psychiatric and Substance Abuse         * 20-99              27       5,142,444
                                  Hospitals.
622310.........................  Specialty (except Psychiatric               0-4              21       8,561,238
                                  and Substance Abuse) Hospitals.
----------------------------------------------------------------------------------------------------------------
* The revenue figure for the smallest size category is unavailable. The revenue figure for the smallest size
  category with available revenue figure is used.

    There are no new costs associated with this proposed rule. The 
labor burden to submit an application is estimated to be the same for 
electronic and paper submissions. No special software is needed to 
complete an online application via DEA's public website. Furthermore, 
all applicants, including the estimated 0.7 percent of applicants using 
paper forms, are assumed to be able to access the internet without 
incurring additional costs. DEA believes using email for contact is 
indicative of having internet access. Although the applicant's contact 
email address is an optional field on a paper registration application, 
virtually all applications submitted include contact email 
addresses.\13\ Although online applications are available at no 
additional cost, DEA acknowledges some applicants have a preference for 
paper forms. DEA does not have a basis to quantify this preference; 
however, DEA believes any costs associated with eliminating this 
preference is offset by the qualitative cost savings discussion below.
---------------------------------------------------------------------------

    \13\ Based on a review of applications submitted from January 
2020 to March 2020, there were 307 applications for initial 
registrations submitted using the paper form. Six of those 307 
applications did not contain a contact email address. Including the 
online applications, six of 30,509 applications for new 
registrations over the three month period, January-March 2020, did 
not contain email addresses.
---------------------------------------------------------------------------

    DEA anticipates there will be cost savings associated with 
electronic submissions. Some cost savings are described qualitatively 
and some are quantified. Many paper applications submitted contain 
illegible or erroneous information or omit required information. Many 
such errors or omissions, such as not including a signature or paying 
the wrong amount, require DEA to contact applicants to correct or 
clarify the information in the paper form, consuming DEA's and the 
applicant's time and resources. Electronic submissions are expected to 
virtually eliminate the requirement for DEA to contact applicants for 
clarifications of form data or correction of submission errors, as 
validation features in the system will flag common errors prior to 
transmission. As DEA has not tracked the number of delays or the 
duration of such delays, DEA does not have a basis to quantify the cost 
savings.
    Furthermore, this proposed rule would eliminate the need to print 
paper forms and transmit by mail or courier service. DEA estimates 
there will be a cost savings of $0.63 ($0.55 for postage plus $0.08 for 
an envelope) per each paper form not submitted. DEA assumes the cost 
savings associated with eliminating printing costs is negligible.
    Therefore, this proposed rule, if promulgated, will not have a 
significant economic impact on a substantial number of small entities.

Unfunded Mandates Reform Act of 1995

    In accordance with the Unfunded Mandates Reform Act of 1995 
(UMRA),\14\ DEA has determined that this action would not result in any 
Federal mandate that may result ``in the expenditure by State, local, 
and tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any 1 year.'' 
Therefore, neither a Small Government Agency Plan nor any other action 
is required under the UMRA.
---------------------------------------------------------------------------

    \14\ 2 U.S.C. 1501, et seq.
---------------------------------------------------------------------------

Paperwork Reduction Act

    This proposed rule would modify existing collection(s) of 
information requirement under the Paperwork Reduction Act (PRA).\15\ 
Pursuant to the PRA,\16\ DEA has identified the collections of 
information below related to this proposed rule. A person is not 
required to respond to a collection of information unless it displays a 
valid OMB control number.\17\
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    \15\ 44 U.S.C. 3501-3521.
    \16\ 44 U.S.C. 3507(d).
    \17\ Copies of existing information collections approved by OMB 
may be obtained at http://www.reginfo.gov/public/do/PRAMain.

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[[Page 1035]]

A. Collections of Information Associated With the Proposed Rule
    1. Title: Application for Registration-DEA 224, Application of 
Registration Renewal-DEA 224A.
    OMB Control Number: 1117-0014.
    Form Number: DEA-224/224a.
    DEA is proposing to amend its regulations for all new and renewal 
registration applications to implement the requirement of online 
submission through the DEA Diversion Control Division website. This 
amendment would improve the submission process by aligning it with the 
Administration's current requirements for other online form 
submissions. The online submission of DEA Forms 224/224a by a Retail 
Pharmacy, Hospital/Clinic, Practitioner, Teaching Institution, or Mid-
Level Practitioner would be filed with DEA through the DEA Diversion 
Control Division secure network (available on the DEA Diversion Control 
Division website). The online submission of new and renewal 
applications through the secure database will ensure the 
Administration's receipt of applications in a more timely and organized 
manner.
    DEA estimates the following number of respondents and burden 
associated with this collection of information:
     Number of respondents: 617,086.
     Frequency of response: 1.
     Number of responses: 617,086.
     Burden per response: 0.202186 \18\
---------------------------------------------------------------------------

    \18\ Calculated based on total annual hour burden and the number 
of respondents (124,766/617,086 = 0.202186).
---------------------------------------------------------------------------

     Total annual hour burden: 124,766.

    2. Title: Application for Registration (DEA Form 225); Application 
for Registration Renewal (DEA Form 225a); Affidavit for Chain Renewal 
(DEA Form 225B).
    OMB Control Number: 1117-0012.
    Form Number: DEA-225/225(A).
    DEA is proposing to amend its regulations for all new and renewal 
registration applications to implement the requirement of electronic 
only submission. This amendment would clarify the submission process by 
aligning it with the Administration's current requirements for other 
online form submissions. The online submission of DEA Forms 225/225a by 
Manufacturer, Distributor, Researcher, Canine Handler, Analytical 
Laboratory, Importer, or Exporter would be filed with DEA through the 
DEA Diversion Control Diversion secure network (available on the DEA 
Diversion Control Division website). The online submission of new and 
renewal applications through the secure database will ensure the 
Administration's receipt of applications in a more timely and organized 
manner.
    DEA estimates the following number of respondents and burden 
associated with this collection of information:

 Number of respondents: 16,338
 Frequency of response: 1
 Number of responses: 16,338
 Burden per response (hour): 0.199106 \19\
---------------------------------------------------------------------------

    \19\ Calculated based on total annual hour burden and the number 
of respondents (3,253/16,338 = 0.199106).
---------------------------------------------------------------------------

 Total annual hour burden: 3,253

    3. Title: Application for Registration (DEA Form 363) and 
Application for Registration Renewal (DEA Form 363a).
    OMB Control Number: 1117-0015.
    Form Number: DEA-363/363a.
    DEA is proposing to amend its regulations for all new and renewal 
registration applications to implement the requirement of online 
submission. This amendment would clarify the submission process by 
aligning it with the Administration's current requirements for other 
online form submissions. The electronic submission of DEA Forms 363/
363a by a Narcotic Treatment Program would be filed with DEA through 
the DEA Diversion Control Diversion secure network (available on the 
DEA Diversion Control Division website). The online submission of new 
and renewal applications through the secure database will ensure the 
Administration's receipt of applications in a more timely and organized 
manner.
    DEA estimates the following number of respondents and burden 
associated with this collection of information:

 Number of respondents: 1,900
 Frequency of response: 1
 Number of responses: 1,900
 Burden per response: 0.187895 \20\
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    \20\ Calculated based on total annual hour burden and the number 
of respondents (357/1,900 = 0.187895).
---------------------------------------------------------------------------

 Total annual hour burden: 357

    4. Title: Application for Registration Under Domestic Chemical 
Diversion Control Act of 1993 and Renewal Application for Registration 
under Domestic Chemical Diversion Control Act of 1993.
    OMB Control Number: 1117-0031.
    Form Number: DEA 510/510a.
    DEA is proposing to amend its regulations for all new and renewal 
registration applications to implement the requirement of online 
submission. This amendment would clarify the submission process by 
aligning it with the Administration's current requirements for other 
form submissions. The electronic submission of DEA Forms 510/510a by a 
Domestic Chemical Handler would be filed with DEA through the DEA 
Diversion Control Diversion secure network (available on the DEA 
Diversion Control Division website). The online submission of new and 
renewal applications through the secure database will ensure the 
Administration's receipt of applications in a more timely and organized 
manner.
    DEA estimates the following number of respondents and burden 
associated with this collection of information:

 Number of respondents: 1,001
 Frequency of response: 1
 Number of responses: 1,001
 Burden per response (hour): 0.182817 \21\
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    \21\ Calculated based on total annual hour burden and the number 
of respondents (183/1,001 = 0.182817).
---------------------------------------------------------------------------

 Total annual hour burden: 183
B. Request for Comments Regarding the Proposed Collections of 
Information
    Written comments and suggestions from the public and affected 
entities concerning the proposed collections of information are 
encouraged. Under the PRA, DEA is required to provide a notice 
regarding the proposed collections of information in the FR with the 
notice of proposed rulemaking and solicit public comment. Pursuant to 
the PRA,\22\ DEA solicits comments on the following issues:
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    \22\ 44 U.S.C. 3506(c)(2).
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     Whether the proposed collection of information is 
necessary for the proper performance of the functions of DEA, including 
whether the information will have practical utility.
     The accuracy of DEA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used.
     Recommendations to enhance the quality, utility, and 
clarity of the information to be collected.
     Recommendations to minimize the burden of the collection 
of information on those who are to respond, including through the use 
of automated collection techniques or other forms of information 
technology.
    All comments concerning collections of information under the PRA 
must be submitted to the Office of Information and Regulatory Affairs, 
OMB, Attention: Desk Officer for the Department of Justice, Washington, 
DC 20503. Please state that your comments refer to RIN 1117-0014, 1117-
0012, 1117-0015, or 1117-0031/Docket No. DEA-587. All comments must be 
submitted to OMB on or before March 8, 2021. The final rule will 
respond to any OMB or public comments on the information collection 
requirements contained in this proposed rule.

[[Page 1036]]

    If you need a copy of the proposed information collection 
instrument(s) with instructions or additional information, please 
contact the Regulatory Drafting and Policy Support Section (DPW), 
Diversion Control Division, Drug Enforcement Administration; Mailing 
Address: 8701 Morrissette Drive, Springfield, Virginia 22152; 
Telephone: (571) 362-3261.

List of Subjects

21 CFR Part 1301

    Administrative practice and procedure, Drug traffic control, 
Security measures.

21 CFR Part 1309

    Administrative practice and procedure, Drug traffic control, 
Exports, Imports, Security measures.

21 CFR Part 1321

    Administrative practice and procedure.

    For the reasons stated in the preamble, DEA proposes to amend 21 
CFR parts 1301 and 1309 as follows:

PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND 
DISPENSERS OF CONTROLLED SUBSTANCES

0
1. The authority citation for part 1301 continues to read as follows:

    Authority:  21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877, 
886a, 951, 952, 956, 957, 958, 965 unless otherwise noted.

0
2. In Sec.  1301.13, revise paragraphs (e)(2) and (3) to read as 
follows:


Sec.  1301.13   Application for registration; time for application; 
expiration date; registration for independent activities; application 
forms, fees, contents and signature; coincident activities.

* * * * *
    (e) * * *
    (2) DEA Forms 224, 225, and 363 may be obtained online at 
www.DEAdiversion.usdoj.gov. Only applications submitted online through 
the secure application portal on DEA's website will be accepted for 
processing.
    (3) DEA will send renewal notifications via email to registrants 
approximately 60 days prior to their registration expiration date. 
Registrants are responsible for keeping their email address current in 
the secure application portal on DEA's website throughout the duration 
of their registration. DEA Forms 224a, 225a, and 363a may be obtained 
online at www.DEAdiversion.usdoj.gov. Only applications submitted 
online through the secure application portal on DEA's website will be 
accepted for processing.
* * * * *
0
3. Amend Sec.  1301.14 by:
0
a. Revising paragraph (a);
0
b. Removing paragraph (b);
0
c. Redesignating paragraphs (c) and (d) as paragraphs (b) and (c); and
0
d. Revising newly redesignated paragraph (b).
    The revisions read as follows:


Sec.  1301.14  Filing of application; acceptance for filing; defective 
applications.

    (a) All applications for registration shall be submitted for filing 
online using the secure application portal at 
www.DEAdiversion.usdoj.gov.
    (b) Application submitted for filing are dated by the system upon 
receipt. If found to be complete, the application will be accepted for 
filing. Applications failing to comply with the requirements of this 
part will be rejected by the system, with the applicate receiving error 
messages at the time of application.
* * * * *

PART 1309--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS 
AND EXPORTERS OF LIST I CHEMICALS

0
4. The authority citation for part 1309 continues to read as follows:

    Authority:  21 U.S.C. 802, 821, 822, 823, 824, 830, 871(b), 875, 
877, 886a, 952, 953, 957, 958.

0
5. Revise Sec.  1309.12 to read as follows:


Sec.  1309.12   Time and method of payment; refund.

    (a) For each application for registration or reregistration to 
manufacture, distribute, import, or export the applicant shall pay the 
fee when the application for registration or reregistration is 
submitted for filing online using the secure application portal at 
www.DEAdiversion.usdoj.gov.
    (b) Payment shall be made online by credit card at the time of 
submission using the secure application portal at 
www.DEAdiversion.usdoj.gov.
0
6. In Sec.  1309.32, revise paragraphs (a) through (c) to read as 
follows:


Sec.  1309.32  Application forms; contents; signature.

    (a) Any person who is required to be registered pursuant to Sec.  
1309.21 and is not so registered, shall apply on DEA Form 510 using the 
secure application portal at www.DEAdiversion.usdoj.gov.
    (b) Any person who is registered pursuant to Section 1309.21, shall 
apply for reregistration on DEA Form 510a using the secure application 
portal at www.DEAdiversion.usdoj.gov.
    (c) DEA Forms 510 and 510a may be obtained online at 
www.DEAdiversion.usdoj.gov. DEA will send renewal notifications via 
email to registrants approximately 60 days prior to their registration 
expiration date. Registrants are responsible for keeping their email 
address current in the secure application portal on DEA's website 
throughout the duration of their registration. Only applications 
submitted online through the secure application portal on DEA's website 
will be accepted for processing.
* * * * *
0
7. Revise Sec.  1309.33 to read as follows:


Sec.  1309.33  Filing of application; joint filings.

    All applications for registration shall be submitted online at 
www.DEAdiversion.usdoj.gov for filing. The appropriate registration fee 
and any required attachments must accompany the application.
0
8. Amend Sec.  1309.34 by revising paragraph (a) to read as follows:


Sec.  1309.34  Acceptance for filing; defective applications.

    (a) Applications submitted for filing are dated upon receipt. If 
the application is found to be complete, the application will be 
accepted for filing. Applications failing to comply with the 
requirements of this part will not be accepted for filing.
* * * * *

PART 1321--DEA MAILING ADDRESSES

0
9. The authority citation for part 1321 continues to read as follows:

    Authority: 21 U.S.C. 871(b).

0
10. Amend Sec.  1321.01 by revising the table heading and the entry 
under ``DEA Registration Section'' to read as follows:


Sec.  1321.01   DEA mailing addresses.

* * * * *

[[Page 1037]]



            Table 1 to Sec.   1321.01--DEA Mailing Addresses
------------------------------------------------------------------------
 Code of Federal Regulations Section--
                 Topic                         DEA mailing address
------------------------------------------------------------------------
 
                              * * * * * * *
------------------------------------------------------------------------
                        DEA Registration Section
------------------------------------------------------------------------
1301.03--Procedures information request  Drug Enforcement
 (controlled substances registration).    Administration, Attn:
1301.18(c)--Research project controlled   Registration Section/DRR, P.O.
 substance increase request.              Box 2639, Springfield, VA
1301.51--Controlled substances            22152.
 registration modification request.
1301.52(b)--Controlled substances
 registration transfer request.
1301.52(c)--Controlled substances
 registration discontinuance of
 business activities notification.
1309.03--List I chemicals registration
 procedures information request.
1309.61--List I chemicals registration
 modification request.
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *

Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-28532 Filed 1-6-21; 8:45 am]
BILLING CODE 4410-09-P